drugset / Trial / NCT04919239

Clinical Trial to Investigate Therapeutic Vaccine (RUTI) Against Tuberculosis (TB)

NCT04919239 ↗

Phase 2 Completed 140 enrolled Archivel Farma S.L.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Prospective, randomized, double-blind, multicentre, placebo-controlled clinical phase IIb trial to evaluate efficacy of RUTI® vaccine in DS- (Drug-Sensitive) and MDR-TB (Multidrug-resistant) patients favourably responding to standard MDR-TB treatment. Time point of vaccination starts upon completion of 1 week of standard DS-TB treatment (cohort A), and another cohort of patients will be vaccinated upon completion of 1 month of standard MDR-TB treatment (cohort B). All the patients will be followed up to the end of the treatment.

Timeline

Start
2021-09-22
Primary completion
2025-06-19
Completion
2025-06-19

Drugs

EvaluationDrugModalityDoseRoute
Subject RUTI® Vaccine 25 ug Intramuscular